SPIRIVA RESPIMAT 2.5 MICROGRAM INHALATION SOLUTION

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Spiriva® Respimat®
2.5 microgram,
inhalation solution
tiotropium
Read all of this leaflet carefully before you start
taking this medicine because it contains important
information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor
or pharmacist.
– This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
What is in this leaflet
1. What Spiriva Respimat is and what it is used for
2. What you need to know before you take Spiriva
Respimat
3. How to take Spiriva Respimat
4. Possible side effects
5. How to store Spiriva Respimat
6. Contents of the pack and other information

Spiriva Respimat helps people who have chronic
obstructive pulmonary disease (COPD) or asthma to
breathe more easily. COPD is a long-term lung disease
that causes shortness of breath and coughing. The
term COPD is associated with the conditions chronic
bronchitis and emphysema. Asthma is a long-term
disease characterised by airway inflammation and
narrowing of the airways. As COPD and asthma are
long-term diseases you should take Spiriva Respimat
every day and not only when you have breathing
problems or other symptoms. When used to treat
asthma you should use Spiriva Respimat in addition
to so-called inhaled corticosteroids and long-acting ß2
agonists.

When taking Spiriva Respimat take care not to let any
spray enter your eyes. This may result in eye pain or
discomfort, blurred vision, seeing halos around lights or
coloured images in association with red eyes (i.e.
narrow angle glaucoma). Eye symptoms may be
accompanied by headache, nausea or vomiting. Wash
your eyes in warm water, stop using tiotropium bromide
and immediately consult your doctor for further advice.

Spiriva Respimat is a long-acting bronchodilator that
helps to open your airways and makes it easier to get
air in and out of the lungs. Regular use of Spiriva
Respimat can also help you when you have on-going
shortness of breath related to your disease, and will
help to minimise the effects of the disease on your
everyday life. Daily use of Spiriva Respimat will also
help to prevent any sudden, short-term worsening of
your COPD symptoms which may last for several days.
For correct dosing of Spiriva Respimat please see
section 3. How to take Spiriva Respimat and the
instructions for use provided on the other side of the
leaflet.

2. What you need to know before you take
Spiriva Respimat

Spiriva® Respimat®
2.5 microgram,
inhalation solution
tiotropium

Please read the following questions carefully. If you
can answer any of these questions with ‘Yes’ please
discuss this with your doctor before taking Spiriva
Respimat.

309869-01

Spiriva® Respimat®
2.5 microgram,
inhalation solution
tiotropium

– are you allergic (hypersensitive) to tiotropium,
atropine or similar drugs such as ipratropium or
oxitropium?
– are you taking any other medicinal products
containing ipratropium or oxitropium?
– are you pregnant, do you think you are pregnant, or
are you breast-feeding?
– are you suffering from blurred vision, eye pain and/
or red eyes, prostate problems or have difficulty
passing urine?
– do you have any kidney problems?
– have you suffered from a myocardial infarction
during the last 6 months or from any unstable or life
threatening irregular heart beat or severe heart
failure within the past year?
Do not use Spiriva Respimat
– if you are allergic (hypersensitive) to tiotropium, its
active ingredient or any of the other ingredients of
this medicine (listed in section 6)
– if you are allergic (hypersensitive) to atropine or
substances related to it, e.g. ipratropium or
oxitropium

Mandatory in

File information

TD

Printfile

Issue date of TD:

17.12.2015

Yes

Yes

PPM SKU:

P005264

No

Yes

PPM SKU version:

013

No

Yes

Issue date of artwork:

13.05.2016

No

Yes

Print colors:

Black

No

Yes

No

Yes

Cyan

Magenta

Yellow
Mat. No. Pack. Site:

309869-01

Min. font size:

10pt

Legend case version:

V4.0 01/OCT/2012 (please do not change or remove it)

Technical information
a = Batch No.

b = Expiry date

c = Manufacturing date

d = Price/Sample/Clinic

Technical colors
BI-Diecut-Legendcase

Free area

Gluepoints

Additional Requirements of Packaging site
Template name: TD-PI_710x274_90x35
Index: a
Only for BI-internal use, Template according to Drawing no.: SP-14-0090-001-B_Index_

MASS D:
MASS E:
MASS G:

0,35 mm
1,0 mm
0,65 mm

Example
Technical information
Control Code Type: Laetus mini

If your breathing has got worse or if you experience
rash, swelling or itching directly after using your inhaler,
stop using it and tell your doctor immediately.
Dry mouth which has been observed with anticholinergic treatment may in the long term be
associated with dental caries. Therefore, please
remember to pay attention to oral hygiene.
Spiriva Respimat is indicated for the maintenance
treatment of your chronic obstructive pulmonary
disease or asthma. Do not use this medicine to treat a
sudden attack of breathlessness or wheezing. Your
doctor should have given you another inhaler (“rescue
medication”) for this.
Please follow the instructions your doctor has given
you.
If you have been prescribed Spiriva Respimat for your
asthma it should be added on to inhaled corticosteroids
and long-acting ß2 agonists. Continue taking the inhaled
corticosteroids as prescribed by your doctor, even if you
feel better.
In case you have suffered from a myocardial infarction
during the last 6 months or from any unstable or life
threatening irregular heart beat or severe heart failure
within the past year, please, inform your doctor. This is
important to decide if Spiriva is the right medicine for
you to take.
Do not take Spiriva Respimat more frequently than once
daily.
You should also contact your doctor if you feel that your
breathing is worsening.
If you have cystic fibrosis, tell your doctor because
Spiriva Respimat could make your cystic fibrosis
symptoms worse.
Children and adolescents
Spiriva Respimat is not recommended for children and
adolescents under 18 years.

Other medicines and Spiriva Respimat
Please tell your doctor or pharmacist if you are taking,
or have recently taken, any other medicines, including
medicines obtained without a prescription.
In particular, please tell your doctor or pharmacist if you
are taking/have taken anticholinergic drugs, e.g.
ipratropium or oxitropium.
No interaction side effects have been reported when
Spiriva Respimat has been taken with other products
used to treat COPD such as reliever inhalers (e.g.
salbutamol), methylxanthines (e.g. theophylline),
antihistamines, mucolytics (e.g. ambroxol), leukotriene
modifiers (e.g. montelukast), cromones, anti-IgE
treatment (e.g. omalizumab) and/or inhaled or oral
steroids (e.g. budesonide, prednisolone).
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be
pregnant or are planning to have a baby, ask your
doctor for advice before taking this medicine. You
should not use this medicine unless specifically
recommended by your doctor.
Driving and using machines
No studies on the effects and the ability to drive and use
machines have been performed. In case dizziness or
blurred vision occurs the ability to drive and use
machinery may be influenced.

3. How to take Spiriva Respimat

If you forget to take Spiriva Respimat
If you forget to take your daily dose (TWO PUFFS ONCE
A DAY), don’t worry. Take it as soon as you remember
but do not take two doses at the same time or on the
same day. Then take your next dose as usual.

Fungal infections of the oral
cavity and throat
(oropharyngeal candidiasis)

Uncommon Uncommon

Difficulties swallowing
(dysphagia)

Rare

If you stop taking Spiriva Respimat
Before you stop taking Spiriva Respimat, you should talk
to your doctor or your pharmacist. If you stop taking Spiriva
Respimat the signs and symptoms of COPD may worsen.

Rash

Uncommon Rare

Itching (pruritus)

Uncommon Rare

Difficulties passing urine
(urinary retention)

Uncommon Not known

Painful urination (dysuria)

Uncommon Not known

Seeing halos around lights or
coloured images in
association with red eyes
(glaucoma)

Rare

Like all medicines, this medicine can cause side effects,
although not everybody gets them.

Increase of the measured eye
pressure

Rare

Not known

Evaluation of the side effects is based on the following
frequencies:

Blurred vision

Rare

Not known

Inflammation of the larynx
(laryngitis)

Rare

Not known

Common:
may affect up to 1 in 10 people
Uncommon:
may affect up to 1 in 100 people
Rare:
may affect up to 1 in 1,000 people
Not known:
frequency cannot be estimated from
the available data

Heart burn (gastrooesophageal
reflux disease)

Rare

Not known

Dental caries

Rare

Not known

Inflammation of the gums
(gingivitis)

Rare

Rare

The side effects described below have been experienced
by people taking this medicine and they are listed
according to frequency as either common, uncommon,
rare or not known.

Inflammation of the tongue
(glossitis)

Rare

Not known

Inflammation of the mouth
(stomatitis)

Not known

Rare

Serious allergic reaction
which causes swelling of the
mouth and face or throat
(angioneurotic oedema)

Rare

Rare

If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4. Possible side effects

Always take this medicine exactly as your doctor has
told you. You should check with your doctor or
pharmacist if you are not sure.
Spiriva Respimat is for inhalation use only.
The recommended dose for adults is:
Spiriva Respimat is effective for 24 hours so you will
need to use Spiriva Respimat only ONCE A DAY, if
possible at the same time of the day. Each time you use
it take TWO PUFFS.
As COPD and asthma are long-term diseases take
Spiriva Respimat every day and not only when you
experience breathing problems. Do not take more than
the recommended dose.
Spiriva Respimat is not recommended for use in
children and adolescents below 18 years due to lack of
data on safety and efficacy.
Make sure that you know how to use your Spiriva
Respimat inhaler properly. The instructions for use of
the Spiriva Respimat inhaler are provided on the other
side of this leaflet.
If you take more Spiriva Respimat than you should
If you take more Spiriva Respimat than two puffs in one
day talk to your doctor immediately. You may be at a
higher risk of experiencing a side effect such as dry
mouth, constipation, difficulties passing urine,
increased heart beat or blurred vision.

Side effect

Frequency
COPD

Frequency
Asthma

Not known

In addition, in common with all inhaled medicines,
some patients may experience an unexpected
tightness of the chest, coughing, wheezing or
breathlessness immediately after inhalation
(bronchospasm).
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side
effects directly (see details below). By reporting side
effects you can help provide more information on
the safety of this medicine.
United Kingdom
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace, IRL – Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra.ie
Malta
ADR Reporting, The Medicines Authority,
Post-Licensing Directorate,
203 Level 3, Rue D’Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt

Blockage of intestines or
absence of bowel movements
(intestinal obstruction,
including ileus paralytic)

Not known

Not known

Feeling sick (nausea)

Not known

Not known

Severe allergic reaction
(anaphylactic reaction)

Not known

Not known

Swelling of joint

Not known

Not known

Faster heart beat (tachycardia) Rare

Common

Not known

Immediate allergic reactions such as rash, nettle
rash (urticaria), swelling of the mouth and face or
sudden difficulties in breathing (angioneurotic
oedema) or other hypersensitivity reactions (such as
sudden reduction of your blood pressure or
dizziness) may occur individually or as part of severe
allergic reaction (anaphylactic reaction) after
administration of Spiriva Respimat. If any of these
occur, please consult your doctor immediately.

Uncommon
Not known

Cough

Uncommon Uncommon

Nosebleed (epistaxis)

Rare

Inflammation of the throat
(pharyngitis)

Uncommon Uncommon

Hoarseness (dysphonia)

Uncommon Uncommon

Tightness of the chest,
associated with coughing,
wheezing or breathlessness
immediately after inhalation
(bronchospasm)

Rare

Constipation

Uncommon Rare

Not known

Uncommon

Do not use this medicine after the expiry date
which is stated on the carton and on the inhaler
label. The expiry date refers to the last day of
the month. Spiriva Respimat inhaler should be
discarded at the latest 3 months after first use
(see Instructions for Use overleaf).
Do not freeze.
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures
will help protect the environment.

Clean the mouthpiece including the metal part
inside the mouthpiece with a damp cloth or
tissue only, at least once a week.
Any minor discoloration in the mouthpiece does
not affect your Spiriva Respimat inhaler
performance. If necessary, wipe the outside of your
Spiriva Respimat inhaler with a damp cloth.

Spiriva Respimat (tiotropium bromide). Read these
Instructions for Use before you start using Spiriva
Respimat.

How to care for your Spiriva Respimat

Introduction

You will need to use this inhaler only ONCE
A DAY. Each time you use it take TWO PUFFS.

When to get a new Spiriva Respimat

1
2
3

Prepare for first use
Remove clear base
• Keep the cap closed.
• Press the safety catch while firmly
pulling off the clear base with your
other hand.

Insert cartridge
• Insert the narrow end of the cartridge
into the inhaler.
• Place the inhaler on a firm surface and
push down firmly until it clicks into
place.

Replace clear base
• Put the clear base back into place
until it clicks.

Daily use

TURN
• Keep the cap closed.
• TURN the clear base in the direction of
the arrows on the label until it clicks
(half a turn).

• If Spiriva Respimat has not been
used for more than 7 days release one
puff towards the ground.

• When the dose indicator enters the red area of
the scale you need to get a new prescription;
there is approximately medication for 7 days
left (14 puffs).

4
5

Turn
• Keep the cap closed.
• Turn the clear base in the direction of
the arrows on the label until it clicks
(half a turn).

Open
• Open the cap until it snaps fully open.

•
•
•
•
•

Press
Point the inhaler toward the ground.
Press the dose-release button
Close the cap.
Repeat steps 4-6 until a cloud is visible.
After a cloud is visible, repeat steps 4-6
three more times.

Answers to Common Questions

Did you turn the clear base? If
not, turn the clear base in a
continuous movement until it
clicks (half a turn).

Did you accidentally turn the
clear base before inserting the
cartridge? Open the cap, press
the dose-release button, then
insert the cartridge.

I cannot press the dose-release
button.

It is difficult to insert the
cartridge deep enough.

Did you insert the cartridge
with the wide end first? Insert
the cartridge with the narrow
end first.

The dose indicator on the
Spiriva Respimat reaches
zero too soon.

OPEN

Did you use Spiriva Respimat
as indicated (two puffs/Once
daily)? Spiriva Respimat will
last 30 days if used at two puffs
once daily.

• OPEN the cap until it snaps fully open.

• The dose indicator shows approximately how
much medication is left.

• If Spiriva Respimat has not been used
for more than 21 days repeat steps 4 to
6 under ‘Prepare for first Use’ until a cloud is
visible. Then repeat steps 4 to 6 three more
times.
• Do not touch the piercing element inside
the clear base.

• Once the dose indicator reaches the end of the
red scale, your Spiriva Respimat locks
automatically – no more doses can be released.
At this point, the clear base cannot be turned
any further.
• Spiriva Respimat should be discarded three
months after you have prepared it for first use,
even if it has not been fully used or used at all.

6

Your inhaler is now ready to use. These steps
will not affect the number of doses available.
After preparation your inhaler will be able to
deliver 60 puffs (30 doses).

Did you turn the clear base
before you inserted the
cartridge? The dose indicator
counts each turn of the clear
base regardless whether a
cartridge has been inserted or
not.

PRESS
• Breathe out slowly and fully.
• Close your lips around the mouthpiece
without covering the air vents. Point your
Inhaler to the back of your throat.
• While taking a slow, deep breath through
your mouth, PRESS the dose-release button
and continue to breathe in slowly for as
long as comfortable.
• Hold your breath for 10 seconds or for as
long as comfortable.
• Repeat TURN, OPEN, PRESS for a total of
2 puffs.
• Close the cap until you use your inhaler again.

Did you spray in the air often to
check whether the Spiriva
Respimat is working? Once you
have prepared Spiriva
Respimat, no test-spraying is
required if used daily.

Is the dose indicator on the
Spiriva Respimat pointing to
zero? The Spiriva Respimat
inhaler is locked after 60 puffs
(30 medicinal doses). Prepare
and use your new Spiriva
Respimat inhaler.

My Spiriva Respimat sprays
automatically.
Was the cap open when you
turned the clear base? Close the
cap, then turn the clear base.
Did you press the dose-release
button when turning the clear
base? Close the cap, so the
dose-release button is covered,
then turn the clear base.
Did you stop when turning the
clear base before it clicked?
Turn the clear base in a
continuous movement until it
clicks (half a turn).

I cannot turn the clear base.

Did you turn the clear base
already? If the clear base has
already been turned, follow
steps “OPEN” and “PRESS”
under “Daily Use” to get your
medicine.
Is the dose indicator on the
Spiriva Respimat pointing to
zero? The Spiriva Respimat
inhaler is locked after 60 puffs
(30 medicinal doses). Prepare
and use your new Spiriva
Respimat inhaler.
My Spiriva Respimat
doesn’t spray.
Did you insert a cartridge? If
not, insert a cartridge.
Did you repeat TURN, OPEN,
PRESS less than three times
after inserting the cartridge?
Repeat TURN, OPEN, PRESS
three times after inserting the
cartridge as shown in the steps
4 to 6 under “Prepare for first
Use”.
Is the dose indicator on the
Spiriva Respimat pointing to
0? If the dose indicator points
to 0, you have used up all your
medication and the inhaler is
locked.
Once your Spiriva Respimat is
assembled, do not remove the
clear base or the cartridge.
Always insert a new cartridge
into a NEW Spiriva Respimat.

Did you insert the cartridge into
a used Spiriva Respimat?
Always insert a new cartridge
into a NEW Spiriva Respimat.